Simvastatin Side Effects
How can Simvastatin Side Effects affect You? | PatientsVille.com
View and Submit Simvastatin Side Effects
Your Simvastatin Side Effect submission can play a very important role. Reporting your experience could help identify an unknown risk and inform other patients and health care professionals.
Record and Track Your Side Effects
It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.
Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Alternative SIMVASTATIN Names:SIMVASTAT
Active Ingredient: SIMVASTAT
Side Effects reported to FDA: 6536. View Simvastatin Adverse Reports
Reported deaths: 418
Reported hospitalizations: 2451
Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations
Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor
[UPDATED 12/15/2011] FDA notified the public that it has revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction.
AUDIENCE: Family Practice, Cardiology, Pharmacy
ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.
BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).
RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.
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Simvastatin Adverse Reactions
Rhabdomyolysis ( 946 Reports)|Myalgia ( 705 Reports)|Renal Failure Acute ( 354 Reports)|Blood Creatine Phosphokinase Increased ( 350 Reports)|Fatigue ( 332 Reports)|Asthenia ( 299 Reports)|Muscular Weakness ( 294 Reports)|Pain In Extremity ( 281 Reports)|Arthralgia ( 248 Reports)|Dizziness ( 200 Reports)|Dyspnoea ( 200 Reports)|Pain ( 195 Reports)|Diarrhoea ( 185 Reports)|Nausea ( 184 Reports)|Muscle Spasms ( 182 Reports)|Fall ( 167 Reports)|Alanine Aminotransferase Increased ( 165 Reports)|Gait Disturbance ( 155 Reports)|Myositis ( 150 Reports)|Vomiting ( 150 Reports)|Headache ( 144 Reports)|Malaise ( 143 Reports)|Myopathy ( 138 Reports)|Renal Failure ( 131 Reports)|Depression ( 123 Reports)|Abdominal Pain ( 121 Reports)|Amnesia ( 120 Reports)|Liver Function Test Abnormal ( 119 Reports)|Aspartate Aminotransferase Increased ( 117 Reports)|Back Pain ( 114 Reports)|